(280 days)
Not Found
Not Found
No
The summary describes a mobility scooter and contains no mention of AI, ML, or related technologies.
No
The device is intended to provide increased mobility and aid independent living, not to treat any ailment.
No
The 'Intended Use / Indications for Use' section explicitly states, "The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability."
No
The device description is not found, but the intended use clearly describes a physical mobility aid ("Breeze Scooter") which is a hardware device.
Based on the provided information, the Breeze Scooter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Breeze Scooter is for providing increased mobility and is an aid to independent living. It explicitly says it "does not provide treatment for any ailment, nor does it have diagnostic capability."
- Nature of IVD Devices: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition. The Breeze Scooter does not interact with or analyze any biological specimens.
Therefore, the Breeze Scooter falls under the category of a mobility aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.
Product codes
INI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
elderly
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Avner Fishbein Afikim Electric Vehicles Kibbutz Afikim, 15148 Israel
Re: K051028 Trade/Device Name: Breeze Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: December 15, 2005 Received: December 19, 2005
Dear Mr. Fishbein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indictions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control (Sections 531-542 of the Act); 21 CFR 1 all II applicane, the elections
1
Page 2 - Mr. Avner Fishbein
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results of basification for your device on your device to alegally
to proceed to the market to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the Division of Small
(301) 442-6507 and its Late Late Lonsumer Assistance at its toll-free number (800) 638-(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely vours.
2
f
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AFIKIM ELECTRIC VEHICLES Kıbbutz Alikim 15148, İsrael Tel: + 972 - 4 - 6: 7 5 4 8 1 4 Fax: + 9 7 2 - 4 - 6 7 5 1 4 5 6 E-mail; mainbox@atiscoolers.com
January 16 2006 Page 1 of 1
Indications for Use
510(k) Number (if known): K051028
Device Name: Breeze
Indications for Use:
The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability.
The Breeze is also suite for the use of elderly persons and physically disabled persons.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
タミやにらんす
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices